Armstrong Sterile Saline Solution
by Armstrong Laboratories, Inc.
PMA P870058
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP870058 | Date13 Oct 1988 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Generic Name
- Accessories, soft lens products
- PMA Number
- FDA Product Code
- LPN
- Device Class
- Class II
- Regulation
- 21 CFR Part 886.5928
- Advisory Committee
- Ophthalmic
- FDA Decision
- APPR Approved
- PMA Supplement
- S001 (Normal 180 Day Track)
Overview
AI-generated summary, 18 Sep 2026
The Armstrong Sterile Saline Solution is classified as Accessories, Soft Lens Products under the Ophthalmic category. It is a sterile, isotonic sodium chloride solution designed for use in ophthalmic procedures, particularly in the handling, storage, and cleaning of soft contact lenses to maintain hydration and comfort.
This solution is supplied in sterile, single-use packaging and is intended for use in clinical and homecare settings. It adheres to FDA regulations under PMA P870058 and 886.5928, ensuring compliance with sterile pharmaceutical standards. The product is non-reusable and must be stored in a clean, dry environment to preserve sterility. No MRI safety information is provided.
Questions
AI-generated answers, 18 Sep 2026
What is the Armstrong Sterile Saline Solution primarily used for in clinical settings?
The Armstrong Sterile Saline Solution is designed specifically for ophthalmic use, particularly to maintain hydration, comfort, and cleanliness of soft contact lenses during handling, storage, and cleaning procedures. It is not intended for any other medical applications.
Is the Armstrong Sterile Saline Solution reusable, or is it meant for single-use only?
The Armstrong Sterile Saline Solution is supplied in sterile, single-use packaging, meaning each unit is intended for one-time use only. This ensures sterility and prevents contamination, which is critical for ophthalmic applications.
How should the Armstrong Sterile Saline Solution be stored to maintain its sterility?
The solution must be stored in a clean, dry environment to preserve its sterility. Since it is non-reusable and pre-packaged, it should remain unopened until use and kept away from moisture or dust to avoid compromising its sterile condition.
What regulatory pathway was followed for the approval of the Armstrong Sterile Saline Solution?
The Armstrong Sterile Saline Solution was authorized through the FDA’s Premarket Approval (PMA) process, specifically under PMA number P870058. This pathway is used for higher-risk devices, ensuring compliance with strict pharmaceutical and sterile standards for ophthalmic accessories.
Are there different sizes or models available for the Armstrong Sterile Saline Solution?
The provided data does not specify distinct sizes or models beyond its classification as a sterile, isotonic sodium chloride solution for soft contact lens care. However, the registration numbers and product codes (e.g., LPN) suggest multiple lot or batch variations may exist, but no specific dimensions or volume differences are detailed.